Important Notes:

The decision to prescribe a compounded medication is made at the sole professional discretion of the prescribing healthcare provider, based upon individualized clinical considerations, including, but not limited to, patient allergies to commercially available ingredients, required dosage forms not otherwise available, or specific formulation needs that cannot be addressed by FDA-approved products.

Patients are hereby advised and acknowledge that compounded medications are not reviewed, evaluated, or approved by the U.S. Food and Drug Administration (FDA) for safety, efficacy, or quality. Compounded formulations are custom-prepared pursuant to a valid prescription and are regulated under applicable state and federal laws governing pharmacy compounding practices; however, they are not subject to FDA approval and have not undergone FDA clinical trials or premarket review.

Fifty 410 only works with fully licensed U.S. pharmacies that comply with all applicable federal and state compounding regulations. Despite these safeguards, compounded medications may carry risks distinct from FDA-approved medications, including potential variability in strength, purity, stability, and effectiveness.

By electing to use a compounded medication, the patient acknowledges and accepts these risks and agrees that the use of such medication is undertaken at the patient’s informed consent and sole risk.

Patients are encouraged to discuss any questions, concerns, or potential risks regarding compounded medications directly with their prescribing provider and/or the dispensing pharmacy.